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Frustrated by TGA? Take a (herbal) chill pill.

Consumers have been campaigning for better regulation and monitoring of complementary medicines for some time.

Dr Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health, adds his voice to the growing concerns about the widespread lack of compliance by the manufacturers of complementary medicines with Australian regulatory requirements.  This article first appeared in The Conversation

If a manufacturer claimed its product was “clinically proven” and could relieve your symptoms of bloating and fatigue, would you believe it?

What about if you were chronically or terminally ill and had tried almost everything else?

The latest audit of complementary therapies found as many as nine out of ten companies made misleading claims about their weight loss products, vitamins, lotions, pills and gadgets.

The release on Tuesday of the Australian National Audit Office’s (ANAO) report on the Therapeutic Goods Administration’s (TGA) performance as regulator of complementary medicine products makes for alarming reading.

The current system of regulation relies on benign oversight from the TGA in what is essentially an “honour system”.

Manufacturers or importers of products (known as sponsors) are simply asked to state that they have evidence that their product is, in some way, effective and is not dangerous to consumers, even if used improperly.

It appears that many manufacturers are happy to provide these assurances but can’t produce the evidence to back them up when the TGA comes knocking.

It’s hard to picture an industry in greater regulatory disarray. So what went wrong?

The ANAO report states that back in 2005, when the regulatory processes were being finalised, the government believed that limited audits would be enough to monitor compliance.

They didn’t foresee that 70 to 90% of sponsors across the entire range of products would mislead consumers.

Around a third of the cases were rated by TGA as “moderate” or “significant”, which includes claims that a product can cure cancer or other serious diseases.

Since 2003, the TGA has allowed sponsors to apply online for listing on the Australian Register of Therapeutic Goods (ARTG). This listing means the product is deemed safe for sale, but does not mean it is deemed effective by TGA.

The process is overseen by a piece of software called the Electronic Listing Facility (ELF).

Since the late 1990s, more of the processing has been done by ELF, and the current version (called ELF 3) has fully delegated powers to approve products for sale if they pass its electronic filter during the listing process.

ANAO identifies a number of problems with this approach, not least of which is that “some sponsors may, on occasions, be entering incorrect information into the ARTG intentionally.”

Back in 2005, the government instructed the TGA to collect, and make public, the clinical evidence that sponsors had provided to demonstrate their products were safe and effective. This hasn’t occurred and the TGA can’t explain why.

There’s an enormous amount of clinical trial evidence about the effectiveness or ineffectiveness of many complementary medicine treatments. But consumers can’t possibly be expected to do their own high-level research.

Sponsors currently take advantage of this by failing to update their advertising claims as new trials are completed and the results published. They know the average Australian isn’t reading academic health care journals.

To add to that, the TGA’s Advertising Code is regularly breached with impunity. In fact, for 2011 alone, out of 82 complaints made about complementary medicine products, all but two have been upheld. (The two that were dismissed were brought by a rival company to the one complained about).

So how can this troubled regulatory process be turned around?

On top of improvements to the TGA’s internal procedures, software and website upgrades (some of which are already underway), ANAO recommends the TGA take a more proactive approach to finding breaches of the regulations.

ANAO investigators did their own trial of “proactive regulation” by searching online for the terms “TGA approved” and “safe”. Both terms are unlawful to use in the advertising of complementary medicines but the report found thousands of examples from Australian websites.

Three examples were so outrageous they reported them to TGA, which promptly ordered the advertising to be changed. When the ANAO checked the websites before finishing their report, two of the three had not complied.

This illustrates the disrespect that the TGA is up against. There’s clearly a need for greater powers of enforcement – but unfortunately this wasn’t recommended in the final ANAO report.

All sides of politics will need to add complementary medicine regulation reform to their long-term health care agendas if any useful change is to be achieved.

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